Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG

Summary

This is a first-in-human, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx2 RabG vaccine in healthy UK volunteers aged 18-65. The vaccine will be administered intramuscularly (IM).

Timeline

Start

2020-01-02

Primary completion

2024-07-10

Completion

2024-07-10

Outcome

Outcome not reported

Stopped (Enrollment): “Since acceptable safety, tolerability, and immunogenicity was demonstrated at the highest dose tested (group 3, fully recruited), there was no scientific or ethical justification to recruit more participants into the mid-dose group (group 2).”

Publications

• Jenkin D, Ritchie AJ, Aboagye J, Fedosyuk S, Thorley L, Provstgaad-Morys S, Sanders H, Bellamy D, Makinson R, Xiang ZQ, Bolam E, Tarrant R, Ramos Lopez F, Platt A, Poulton I, Green C, Ertl HCJ, Ewer KJ, Douglas AD. Safety and immunogenicity of a simian-adenovirus-vectored rabies vaccine: an open-label, non-randomised, dose-escalation, first-in-human, single-centre, phase 1 clinical trial. Lancet Microbe. 2022 Sep;3(9):e663-e671. doi: 10.1016/S2666-5247(22)00126-4. Epub 2022 Jul 27.

Drugs

Indications